(184 days)
The Gerson 1730 N95 Particulate Respirator is intended to be worn by operating room personnel during healthcare procedures to protect both the patient and healthcare professionals from the transfer of microorganisms, bodily fluids and particulate material.
This device also meets CDC guidelines for TB exposure.
Subject device is also a surgical mask and is single use / disposable.
The 1730 N95 Particulate Respirator and Surgical Mask is constructed from a white nonwoven material used for the inner and outer shell. The polypropylene meltblown filter media is layered between the inner and outer shell. The headband is made of elastic and welded to the mask. The inside nosepiece is made of an open celled foam and the outside nosepiece, which conforms to the nose, is made of aluminum.
The 1730 N95 Particulate Respirator is approved by NIOSH as per 42 CFR 84. The certification number assigned is TC-84A-160 for a type N95 Particulate Respirator. The N95 must meet the prescribed test criteria of a 0.3 micron diameter challenge and requiring a 95% efficiency. This mask is also fluid resistant as per the ASTM D583-65 Method 1 and is resistant to synthetic blood as per protocol number 9602202-01 conducted by Nelson Laboratories. Breathing resistance was tested as per 42 CFR 84.
The provided text describes a 510(k) premarket notification for the "Gerson 1730 N95 Particulate Respirator," which is seeking substantial equivalence to a predicate device. This document does NOT describe the acceptance criteria and study proving a device meets acceptance criteria in the way typically found for software or AI/ML devices with specific performance metrics (e.g., sensitivity, specificity).
Instead, this document focuses on confirming that the N95 respirator meets regulatory standards and performance equivalence for a physical product. The "acceptance criteria" here are defined by the required performance for an N95 respirator and surgical mask designation, and the "study" refers to the testing performed to demonstrate these physical properties.
Here's a breakdown based on the provided text, adapted to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Particulate Filtration Efficiency (NIOSH N95) | 95% efficiency against a 0.3 micron diameter challenge | Meets prescribed test criteria of a 0.3 micron diameter challenge, requiring 95% efficiency. Certified by NIOSH with certification number TC-84A-160 for a type N95 Particulate Respirator. The device incorporates a highly efficient filter media and is 95% efficient against a 0.3 micron particulate size. |
| Fluid Resistance (Surgical Mask) | Resistance to synthetic blood | Fluid resistant as per ASTM D583-65 Method 1. Resistant to synthetic blood as per protocol number 9602202-01 conducted by Nelson Laboratories. |
| Breathing Resistance | Not explicitly quantified, but must meet standards | Tested as per 42 CFR 84. (Assumed to meet standards, as no issues reported.) |
| CDC Guidelines for TB Exposure Control | Compliance with guidelines | Meets CDC Guidelines for TB Exposure Control. |
| Disposable Single Use | Disposable | Described as a disposable single use mask. |
| Substantial Equivalence (Overall) | Comparable in manufacturing, materials, and performance | Found substantially equivalent to the Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735. Manufactured in the same manner with minor material/construction differences (welded elastic headbands vs. stapled rubber, open-celled foam vs. closed-cell foam), while maintaining the same efficiency. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size for the test set" in the context of clinical data or image sets. It refers to a physical product undergoing standardized testing.
- For Particulate Filtration Efficiency and Breathing Resistance: These tests are conducted according to NIOSH standards (42 CFR 84). The sample size for such physical product testing is typically defined by the standard and involves a set number of units. The document does not explicitly state the number of units tested but implies compliance with the standard which would dictate this.
- For Fluid Resistance: "Protocol number 9602202-01 conducted by Nelson Laboratories." While the specific number of masks tested isn't given, Nelson Laboratories is a reputable testing facility, implying adherence to their established protocols for sample size.
- Data Provenance: The testing was performed by NIOSH (for N95 certification) and Nelson Laboratories (for fluid resistance). This implies controlled laboratory settings and not human subject data from a specific country or retrospective/prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this device. The "ground truth" for a physical respirator's performance is established through objective, standardized engineering and material science tests, not through expert clinical consensus for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or adjudication involved in the objective measurements of filtration efficiency, fluid resistance, or breathing resistance. These are direct measurements comparing physical properties to established benchmarks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is a physical N95 respirator, not an AI/ML-based diagnostic or assistive device. Therefore, no MRMC studies or AI assistance are relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical N95 respirator, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Standardized Test Methods and Criteria: Primarily NIOSH (National Institute for Occupational Safety and Health) standards for N95 respirators (42 CFR 84) and ASTM (American Society for Testing and Materials) standards (ASTM D583-65 Method 1) for fluid resistance.
- Predicate Device Performance: Demonstrating that the new device performs equivalently to a legally marketed predicate device (Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735).
8. The Sample Size for the Training Set
Not applicable. This is a physical product and does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no corresponding establishment of ground truth for a training set.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.